The present invention relates an apparatus to fix tubes, electric wires, and the like which pass through the skin of the living body, to the skin of the living body, that is, a skin button. More particularly, the present invention relates to an apparatus which is established at the site where tubes or electric wires pass through the skin of the living body which connect an organ in the living body or an artificial organ such as an artificial heart or an artificial heart-lung with an equipment and the like outside the body, and which sustains tubes, electric wires, and the like to the skin of the living body, the tubes and electric wires are fixed to the skin of the living body as they pass through the skin.
Conventionally, a procedure has been performed, where a tube is inserted into the living body by passing through the skin of the living body to inject pharmaceutical solution to an organ in the living body or to drain body fluid and the like from the living body. A procedure has also been performed where an electric wire is inserted into the living body by passing through the skin of the living body to pickup a signal from various detectors implanted in the living body. Moreover, tubes and electric wires have been inserted into the living body which connect an artificial organ implanted in the body such as an artificial heart or an artificial heart-lung with an equipment outside the body and supply pharmaceutical solution on electric power to the artificial organ. Various apparatus other than the above may be left in place as they pass through the skin of the living body for various purposes.
When the above tubes or electric wires, or any other apparatus are left in place as they pass through the skin of the living body for a long time, it is necessary to fix and sustain them to the skin as well as to give such a treatment to prevent invasion of bacteria into the body from this penetrating site.
Conventionally, a tabular component has been stuck to the surface of the skin around the penetrating site where a tube or an electric wire pass through the skin which, for example, connects an artificial heart implanted in the body and an equipment outside the body in order to make the above tube or electric wire pass through that component. In such a component, a load applied to the tube or the electric wire is transmitted dispersedly to the surrounding skin via that tabular component, whereby the tube or the like is fixed to the skin.
However, such a tabular component is stuck to the skin, so that when the skin moves because of body activity in use of the above component, the tabular component cannot coordinate with that movement of the skin, which may make the user feel discomfort or a pain. The above tabular component, which is stuck to the surface of the skin, is possible to move due to the elasticity of the skin. Therefore, when an external force is applied to this tube and the like, this tabular component moves, and as a consequence, the external force applied to the tube may be exerted on the through hole, causing a pain. Moreover, such a component allows possible invasion of bacteria from the site between the tube and the through hole of the skin.
Coating with a biocompatible material of the surface of a component like the above one which is left in the living body for a long time has been practiced conventionally. Such a measure allows sticking of the living tissue to the component, sustaining of the component to the living tissue, and prevention of viral invasion from the site where the component is buried. Such biocompatible materials include carbon materials, titanium, fluororesin, hydroxyapatite and the like, which are used as dental and bone prostheses.
However, the component of the present invention which is left in the living tissue as it passes through the skin, that is, a skin button, did not show sufficient bonding to the living tissue when the above conventional biocompatible materials were used.
In the past, a component to be left in the living body itself has been made of the above material, or alternatively, a component made of another material has had its surface coated with the above biocompatible material. Thus there has not been sufficient bonding of the surface of that component to the living tissue, which might cause a slippage between the surface of that component and the living tissue.
Therefore, the above tube which has its surface coated with a biocompatible material as was the case in the past will cause the movement of this tube due to distortion of the skin, cause some slippage between the penetrating site and the living body, and make the user feel a pain, and may allow the invasion of virus from the site.